The development of a technology-based information support intervention (iSupport) among patients with differentiated thyroid cancer post radioactive iodine therapy

针对放射性碘治疗后分化型甲状腺癌患者开发基于技术的信息支持干预 (iSupport)

• 批准号: 10581121
• 负责人: Alaina L Carr
• 金额: $ 13.1万
• 依托单位: GEORGETOWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-03-02 至 2025-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10581121
• 关键词: Address; Adverse effects; Aftercare; Appointment; Behavior Therapy; Behavioral; Behavioral Model; Cancer Control; Cancer Patient; Caring; Cellular Phone; Clinical; Clinical Trials Design; Computers; Control Groups; Coping Skills; Data; Development; Devices; Diagnosis; Distress; Education; Educational Intervention; Eligibility Determination; Endocrine; Enrollment; European Organization for Research and Treatment of Cancer; Evidence based intervention; Feedback; Focus Groups; Follicular thyroid carcinoma; Frequencies; Frustration; Functional disorder; Future; Goals; Gold; Grant; Individual; Information Management; Intervention; Interview; Knowledge; Lacrimal gland structure; Late Effects; Leadership; Malignant Neoplasms; Malignant neoplasm of thyroid; Measures; Mentors; Mentorship; Nose; Online Systems; Oral health; Pain; Papillary Carcinoma; Participant; Patient Selection; Patient-Focused Outcomes; Patients; Persons; Phase; Population; Prognosis; Provider; Radioactive Iodine; Randomized; Randomized, Controlled Trials; Recommendation; Reporting; Research; Research Design; Research Personnel; Salivary; Salivary Glands; Second Primary Cancers; Self Efficacy; Sleep; Social Functioning; Stress; Survival Rate; Symptoms; System; Technology; Testing; Training; Treatment Efficacy; Treatment Side Effects; Writing; acceptability and feasibility; alternative treatment; cancer therapy; cancer type; career development; common symptom; coping; design; digital health; digital technology; empowerment; experience; follow-up; health related quality of life; improved; intervention effect; lacrimal; novel; oral mucositis; patient population; pilot test; primary outcome; radioiodine therapy; reduce symptoms; secondary outcome; side effect; skills; social cognitive theory; support tools; survival outcome; survivorship; symptom management; symptom treatment; therapy design; therapy development; tool; treatment as usual; treatment comparison; treatment effect; understudied cancer; usability; web-based intervention

Abstract Radioactive iodine (RAI) therapy is routinely used among patients diagnosed with differentiated thyroid cancer (DTC), with approximately 76% of patients receiving RAI. Patients with DTC post RAI treatment report extensive short-term and late effects of treatment, symptom burden, and unmet informational needs about treatment related side effects. However, thyroid cancer is frequently referred to as the “good cancer” and is an understudied cancer population for survivorship research and web-based interventions. One way to address these gaps is through digital technologies such as a web-based intervention, which can empower patients with direct access to educational and support tools to reduce symptom burden. I propose to develop and evaluate a web-based intervention, called iSupport (informational support among patients post RAI treatment), to reduce symptom burden among patients diagnosed with DTC post RAI. I propose the following aims: Aim 1 (K99). Develop iSupport, a web-based intervention, for patients with DTC post RAI therapy. Aim 2 (K99). Test the usability of the newly developed iSupport intervention among patients with DTC post RAI. Aim 3 (R00). Assess the feasibility and acceptability of the iSupport intervention. Aim 4 (R00). Test the preliminary efficacy of the iSupport intervention vs. treatment as usual (TAU) among patients with DTC on symptom burden. The K99 phase will involve: 1) conducting patient focus groups (N=32) and individual stakeholder interviews (N=12) to develop iSupport and 2) testing the usability of the iSupport intervention among patients with DTC post RAI therapy (N=8). The R00 phase will involve conducting a pilot randomized controlled trial (RCT; N=72) to: 1) assess the feasibility and acceptability of iSupport and 2) test the preliminary efficacy of iSupport compared to a (TAU) control group with DTC patients on RAI-related symptom burden, patient bioheath indicators (oral mucositis; oral health problems), knowledge of DTC and RAI, self-efficacy for coping with side effects, cancer- related distress, and health-related quality of life. The overall objective of the K99/R00 is to provide Dr. Carr with training and mentorship to become an independent cancer control investigator with expertise in digital technology evidenced-based interventions among cancer patients. The K99 training goals include: 1) increase knowledge of clinical concerns and symptoms among patients with DTC post RAI, 2) obtain advanced training in technology-based intervention design and development, 3) develop expertise in behavioral intervention clinical trials design and testing, and 4) refine grant writing and leadership skills for future independence. Dr. Carr’s mentorship team includes Drs. Kristi Graves (primary), Jacqueline Jonklaas (co-mentor), and Kristen Miller (co-mentor) who are committed to her career development. The proposed training plan will facilitate Dr. Carr’s transition to independence as a cancer control researcher with expertise in digital health interventions to reduce symptom burden and improve health-related quality of life in cancer patient outcomes after treatment.

抽象的 放射性碘 (RAI) 疗法通常用于诊断为分化型甲状腺癌的患者 (DTC)，大约 76% 接受 RAI 的患者报告 RAI 治疗后出现 DTC。 治疗的广泛短期和后期影响、症状负担以及未满足的信息需求 然而，甲状腺癌通常被称为“好癌症”，是一种治疗相关的副作用。 对癌症人群进行了充分研究，以进行生存研究和基于网络的干预措施。 这些差距是通过数字技术实现的，例如基于网络的干预措施，它可以使患者能够 直接获得教育和支持工具以减轻症状负担 我建议开发和评估一个 基于网络的干预措施，称为 iSupport（RAI 治疗后患者之间的信息支持），以减少 RAI 后诊断为 DTC 的患者的症状负担我提出以下目标：目标 1 (K99)。 为 RAI 治疗后 DTC 患者开发 iSupport，这是一种基于网络的干预措施。 新开发的 iSupport 干预措施在 RAI 后 DTC 患者中的可用性。 评估 iSupport 干预的可行性和可接受性。 测试初步效果。 DTC 患者的 iSupport 干预与常规治疗 (TAU) 的症状负荷比较。 K99 阶段将涉及：1) 进行患者焦点小组 (N=32) 和个人利益相关者访谈 (N=12) 开发 iSupport 并 2) 测试 iSupport 干预在 RAI 后 DTC 患者中的可用性 治疗（N=8）。R00 阶段将涉及进行试点随机对照试验（RCT；N=72）：1) 评估 iSupport 的可行性和可接受性，2) 测试 iSupport 的初步功效（与其他产品相比） a (TAU) 对照组，其中 DTC 患者的 RAI 相关症状负担、患者生物健康指标（口腔 口腔健康问题）、DTC 和 RAI 知识、应对副作用的自我效能、癌症- K99/R00 的总体目标是为卡尔博士提供相关的痛苦和健康相关的生活质量。 通过培训和指导，成为一名具有数字专业知识的独立癌症控制调查员 K99 培训目标包括：1) 增加对癌症患者的基于技术的干预。 了解 RAI 后 DTC 患者的临床问题和症状，2) 获得高级培训 基于技术的干预设计和开发，3）发展行为干预方面的专业知识 临床试验设计和测试，以及 4) 完善拨款写作和领导技能，以实现未来的独立性。 卡尔的导师团队包括 Kristi Graves 博士（主要）、Jacqueline Jonklaas（联合导师）和 Kristen。 米勒（共同导师）致力于她的职业发展，拟议的培训计划将有利于博士。 卡尔作为一名癌症控制研究人员过渡到独立，拥有数字健康干预方面的专业知识 减少癌症患者治疗后的症状负担并改善与健康相关的生活质量。